May 18, 2011
Science Advisory Board Meeting Minutes
May 18, 2011
Saltonstall Building: 2nd Floor
1 PM
Members Present: Dave Williams, Larry Boise, Martha Mittelstaedt, Hilary Hackbart, Robin Dodson, Anne Marie Desmarais, Veronica Vieira
Others Present: Heather Tenney (TURI), Mary Butow (TURI), Rich Bizzozero (OTA), Carol Rowan West (DEP), John Raschko (OTA), Liz Harriman (TURI), Dr. Sandra Baird (DEP), Tricia McCarthy (ACC), Sean Moynihan (MCTA), Dave Wawer (MCTA), Dr. Bob Golden (ToxLogic, for ACC), Bill Coyne (ACC)
Welcome and Introductions
Program Updates
• There have been many demonstration sites, continuing education and community conferences this spring.
• The RFP for Community Grants is now out.
• The Administrative Council and Advisory Committee are currently looking at potential Priority User Segments for our first Higher Hazard Substances. They are currently considering TCE in cleaning operations.
• The Administrative Council voted to make Hexavalent Chromium Compounds a separate category and a Higher Hazard Substance.
• The State House Event is June 2, 2011 – all are welcome/encouraged to attend.
• OTA updated that the Board of Cosmetology may take action on formaldehyde at their May meeting
March Minutes
• Motion to approve minutes: 5 in favor, 1 abstain
Formaldehyde
The substance was last discussed by the Board in October. Heather reviewed the discussion/activity on formaldehyde to this point.
• In 1999, the SAB voted for the substance to be included on the More Hazardous List.
• In 2006, formaldehyde was included on the list of 10 Candidates for HHS. Also in this year, IARC revised their designation of formaldehyde from Group 2A (probably carcinogenic to humans) to Group 1 (carcinogenic to humans), based on what IARC concluded to be sufficient evidence of nasopharyngeal cancer in humans, strong but not sufficient evidence of leukemia in humans, and limited evidence of sinonasal cancer in humans (IARC 2006).
• In 2009, IARC reaffirmed the Group 1 designation and noted there was now sufficient evidence of leukemia in humans.
• The Board indicated in October, if no data in the NAS review of EPA’s draft IRIS assessment of Formaldehyde conflicts w/ the NPC carcinogen designation, then they would recommend formaldehyde as a HHS.
• The NTP draft assessment and the NCI Hauptmann study were distributed in the interim as additional background reading.
Dr. Sandra Baird (a member of the NAS panel and a DEP staff member) spoke about the process and results of the NAS committee review of the 1,000 page draft EPA IRIS assessment for formaldehyde. She reviewed the charge to the NAS committee, specifically what they were asked to comment on. The committee met in June/October/December of 2010. They divided reviewing tasks. Presentations were made by EPA/ACC/others. The committee did not review IARC or NTP or statements by others.
With regard to health effects:
• NAS agreed with EPA’s Nasopharyngeal Cancer (NPC) assessment
• Regarding Lymphohematopoietic Cancers (LHPs) NAS felt EPA didn’t support causality with the current info. NAS stated that individual LHPs should be considered separately.
• Non-cancer effects– irritant, eye, nose, throat, decreased pulmonary function.
• Asthma – there is some evidence but the link is not clear. There is a need for updated studies.
A Program Staff member inquired if the suggestion to use the BBDR model in any way negated the NPC designation. Dr. Baird noted it did not, and explained the rationale behind the further discussion of the BBDR and its suggested use. A Board member had a question regarding the genotoxic mode of action. Dr. Baird noted that if the concentration was below that which would cause cytotoxicity, then the exposure would not cause a tumor. The evidence was not sufficient to choose one model over another (or possibly another option).
Dr. Bob Golden (of ToxLogic, for ACC) handed out and reviewed a series of slides with comments on the conclusions of the NAS panel’s review of the EPA/IRIS formaldehyde assessment. He highlighted the Marsh et al study and noted that exposures of 6ppm or greater are necessary for cancer response. He noted that information from the Hauptmann study (currently undergoing revision) may be useful. It was found that there were missing deaths in the study which prompted the revision. This could significantly change the results of the study, particularly SMR values.
A Board member asked if there are currently studies trying to remove the nasopharyngeal cancer designation. Dr. Golden noted that it would be difficult. Also health effects experienced occupationally in a popular salon treatment called the ‘Brazilian blowout’ were discussed.
It was indicated that the mode of action was a concern for all systemic effects. It was stated that there was definitely greater uncertainty with regard to leukemia vs. NPC.
Motion: Since no data in NAS report conflicts with IARC’s NPC classification, the SAB recommends retaining their recommendation of formaldehyde on the HHS candidate list of 11 substances.
Vote: Favor (5), Against (1), Abstain (1)
The Board indicated that the nasopharyngeal cancer designation was the primary reason for the vote in favor. Specifically, a member indicated that there was sufficient evidence of genotoxicity. Those who voted against/abstained noted they did so mainly due to the conflicts found in EPA’s presentation of data and the criticisms of the overall EPA report. Program staff noted that we will continue to follow the studies with regard to formaldehyde.
A member also noted that it would be useful to re-visit the discussion regarding the list of HHS candidates in the fall, with the intention of possibly updating the list of HHS candidates.
Reproductive toxicants
A sheet of substances currently on the TURA list (generated by a student intern working with TURI), which also appear on the Prop 65 list, was circulated to the Board. Board members were asked to review this list and indicate if they felt any substances should be added or removed from the list. The Board indicated that it would like to see the list of substances that are on Prop 65 and NOT on TURA. This will be distributed at the next meeting.
Certain Halogenated Compounds Category
Heather distributed the master sheet of CHCC and Mary noted the key for highlighted cells in the sheet. The Board is being asked to note if there are any interesting trends/commonalities from an environmental health and safety perspective.
A program staff member asked for 1-Bromopropane to be added to list. SAB members had a few questions regarding the data set, mainly what was the basis for citations of neurotoxicity and reproductive effects. TURI will research this and report back to the Board. Other feedback on the current set included a comment regarding substances that exist on the Montreal Protocol List based on their Ozone Depleting Potential, which would not be an issue since they are scheduled to be banned. TURI will verify which of the current substances are on the Montreal Protocol list.
A list of ‘theoretical substances’ was also distributed. This list contains substances which do not currently have a CAS RN number, but have been included based on structural similarities to other halogenated substances on the list. A member commented that many of the iodine substituted substances are probably solids.
A visitor inquired about the process and if this is the first time we were considering such a grouping of substances. There was also concern about whether this would create an additional reporting burden. Board members indicated it should not, and as in the case of the hexavalent chromium category will likely simplify reporting.
Some other comments from the Board included a lack of interest in pesticides, e.g. CCl4 which are not likely to be used. Also a member requested that they consider the substances by individual halogen. With this in mind TURI will bring chlorinated substances for consideration at the next meeting.
Finally, TURI noted we have contacted EPA for additional information on structure activity relationships. They have sent some preliminary information for review. We will be speaking with them in the future once we have clarified the types of information we are seeking.
Next Meeting: Tuesday, June 14th @ DEP